Support structures and methods of using the same

ABSTRACT

According to an aspect of the present disclosure, an apparatus for forming an anastomosis between adjacent intestinal sections of tissue is provided. The apparatus includes an anastomosis device having an anvil and a tubular body portion, wherein the anvil is selectively attachable to the tubular body portion by a shaft; and a support structure for deposition between the intestinal sections of tissue. The support structure includes a body defining an aperture therein for receiving the shaft. The body has an outer terminal edge. The support structure includes at least one layer of expandable material disposed at the outer terminal edge of the body.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a divisional of U.S. application Ser. No. 11/241,267filed Sep. 30, 2005, now U.S. Pat. No. 7,938,307 which claims benefit ofapplication No. 60/620,066 filed Oct. 18, 2004, which claims benefit ofapplication No. 60/620,065 filed Oct. 18, 2004, and the disclosures ofeach of the above-identified applications are hereby incorporated byreference in their entirety.

BACKGROUND

1. Technical Field

The present disclosure relates to support structures and, moreparticularly, to annular support structures, gaskets and the like foruse in conjunction with stapling devices, for reducing occurrences ofleaking, bleeding and/or stricture.

2. Background of Related Art

Staples have traditionally been used to replace suturing when joining oranastomosing various body structures, such as, for example, the bowel orbronchus. The surgical stapling devices employed to apply these staplesare generally designed to simultaneously cut and seal an extendedsegment of tissue in a patient, thus vastly reducing the time and risksof such procedures.

Linear or annular surgical stapling devices are employed by surgeons tosequentially or simultaneously apply one or more linear rows of surgicalfasteners, e.g., staples or two-part fasteners, to body tissue for thepurpose of joining segments of body tissue together and/or for thecreation of anastomoses. Linear surgical stapling devices generallyinclude a pair of jaws or finger-like structures between which bodytissue to be joined is placed. When the surgical stapling device isactuated and/or “fired”, firing bars move longitudinally and contactstaple drive members in one of the jaws, and surgical staples are pushedthrough the body tissue and into/against an anvil in the opposite jawthereby crimping the staples closed. A knife blade may be provided tocut between the rows/lines of staples. Examples of such surgicalstapling devices are described in U.S. Pat. Nos. 4,354,628, 5,014,899and 5,040,715, the entirety of each of which is incorporated herein byreference.

Annular surgical stapling devices generally include an annular staplecartridge assembly including a plurality of annular rows of staples,typically two, an anvil assembly operatively associated with the annularcartridge assembly, and an annular blade disposed internal of the rowsof staples. Examples of such annular surgical stapling devices aredescribed in U.S. Pat. Nos. 5,799,857 and 5,915,616 to Robertson et al.,the entirety of each of which is incorporated herein by reference.

For most procedures, the use of bare staples, with the staples in directcontact with the patient's tissue, is generally acceptable. Theintegrity of the tissue will normally serve to prevent the staples fromtearing out of the tissue and compromising the sealing before healinghas occurred. However, in some surgical operations, surgical supports,e.g., meshes, are employed by surgeons to bridge, repair and/orreinforce tissue defects with a patient, especially those occurring inthe abdominal wall, chest wall, diaphragm and other musculo-aponeuroticareas of the body. Examples of surgical supports are disclosed in U.S.Pat. Nos. 3,054,406, 3,124,136, 4,347,847, 4,655,221, 4,838,884 and5,002,551, the entirety of each of which is incorporated herein byreference.

When the staples are applied in surgical procedures utilizing surgicalsupports (i.e., reinforcing material), the legs of the staple typicallypass from the cartridge jaw through a layer of the surgical support, andthrough the patient's tissue before encountering the anvil jaw. In analternative procedure, the legs of the staple typically pass from thecartridge jaw through a first layer of the surgical support, thenthrough the patient's tissue, and finally through a second layer of thesurgical support before encountering the anvil jaw. With the staples inplace, the stapled tissue is clamped between the layers of the surgicalsupport.

While the surgical supports described above are used in conjunction withlinear surgical stapling devices, the need exists for annular supportstructure for use in conjunction with annular or circular surgicalstapling devices, for example, an end-to-end anastomosis stapler such asa Model “EEA™” instrument available from United States Surgical, aDivision of Tyco Health-Care Group, LP, Norwalk, Conn. and disclosed inU.S. Pat. No. 5,392,979 to Green et al. In general, an end-to-endanastomosis stapler typically places an array of staples into theapproximated sections of a patient's bowels or other tubular organs. Theresulting anastomosis contains an inverted section of bowel whichcontains numerous “B” shaped staples to maintain a secure connectionbetween the approximated sections of bowel.

In addition to the use of surgical staples, biological tissue adhesiveshave been developed for tissue repair and the creation of anastomoses.Generally, biological adhesives bond separated tissues together to aidin the healing process and to enhance the tissue strength. Suchadhesives may be used instead of suturing and stapling, for example, insurgical procedures, for the repair of tissue or the creation ofanastomoses.

In addition to the use of biological adhesives, following the formationof the anastomosis, a separate instrument or device is used to applybiological sealants to the outer surface of the anastomosis. Typically,in a separate step, the biological sealants are applied to the outersurface of the anastomosis by spraying on, brushing on, swabbing on, anycombinations thereof, or any other method contemplated by those skilledin the art. The biological sealants act to reduce and/or stop theincidents of leakage from the anastomosis.

One possible side effect of any end-to-end bowel anastomosis is itstendency to stenos over time, which stenosis can decrease the diameterof the lumen over time. Accordingly, the need exists for a surgicalsupport structure which operates in conjunction with any end-to-endanastomosis device and assists in maintaining the lumen of theanastomosed bowel or other tubular organ open over time.

The application of suitable biocompatible adhesive offers manyadvantages to the patient and the surgeon alike, such as, for example,the possible reduction in the number of staples used, immediate sealingof the tissue being treated, a strengthening of the anastomosis, and areduction in the occurrence of bleeding from the blood vessels, leakagethrough the tissue joint, and stricture. Moreover, use of biocompatibleadhesives tends to minimize foreign body reaction and scarring.

Accordingly, the need exists for an annular support structure whichoperates in conjunction with any end-to-end, annular or circularstapling device and assists in maintaining the lumen of the anastomosedbowel or other tubular organ patent or open over time.

A need also exists for an annular support structure which operates inconjunction with any end-to-end, annular or circular stapling device toreduce the trauma suffered by the patient, reduce the instances ofleakage, reduce the instances of bleeding, and create a relativelystrong bond between adjacent body tissues.

A need also exists for an annular support structure configured toprovide support to the anastomosed tissue, preferably, distally and/orproximally of the staple line.

SUMMARY

According to an aspect of the present disclosure, an apparatus forforming an anastomosis between adjacent intestinal sections of tissue isprovided. The apparatus includes an anastomosis device having an anviland a tubular body portion, wherein the anvil is selectively attachableto the tubular body portion by a shaft; and a support structure fordeposition between the intestinal sections of tissue. The supportstructure includes a body defining an aperture therein for receiving theshaft. The body has an outer terminal edge. The support structureincludes at least one layer of expandable material disposed at the outerterminal edge of the body.

The at least one layer of expandable material may include a first and asecond membrane extending radially outward from the outer terminal edgeof the body.

The aperture may be defined by an inner terminal edge of the body. Theinner terminal edge may be disposed radially inward of staple receivingslots of a staple cartridge assembly disposed in the tubular body.

It is envisioned that each of the first and second membranes is madefrom a polymeric film, such as, for example, polyethylene. The supportstructure has an undeployed condition wherein the first and secondmembranes are rolled-up towards the body, and a deployed conditionwherein the first membrane extends in a substantially distal directionfrom the body and the second membrane extends in a substantiallyproximal direction from the body.

The apparatus may further include a rip-cord for expanding the first andsecond membranes. The rip-cord is rolled-up into each of the first andsecond membranes when the support structure is in the undeployedcondition.

Each membrane may include a first inner layer and a second outer layer.The second outer layer of each membrane may swell at a rate greater thanthe first inner layer. The second outer layers of the first and secondmembranes are made from a hydrogel. The first inner layer of each of thefirst and second membranes may be constructed from a substantiallynon-absorbable material. The first inner layer of each of the first andsecond membranes may be fabricated from a bio-absorbable mesh fabric.

According to another aspect of the present disclosure, a method ofdisposing a support structure between adjacent intestinal sections isprovided. The method includes the step of providing a circular surgicalanastomosis device. The circular surgical anastomosis device includes ananvil assembly having an anvil member and a first shaft; and a tubularbody portion having an annular knife operatively disposed therein and asecond shaft disposed radially inward of the annular knife, the firstshaft of the anvil assembly being selectively attachable to the secondshaft of the tubular body.

The method further includes the steps of inserting the anvil assemblyinto a first intestinal section; inserting the tubular body portion intoa second intestinal section; disposing a support structure between thefirst intestinal section and the second intestinal section, the supportstructure having at least one layer of expandable material;approximating the anvil assembly and tubular body portion with oneanother so that an end portion of the first intestinal section, thesupport structure, and an end portion of the second intestinal sectionare disposed between the anvil member and the tubular body portion, thesupport structure being disposed between the first intestinal sectionand the second intestinal section; firing the surgical anastomosisdevice to sever the portions of the first and second intestinal sectionsdisposed radially inward of the annular knife, and to touch the portionsof the first and second intestinal sections radially outward of theannular knife against the structure; and expanding the at least onelayer of expandable material

The anvil assembly may include a first shaft and the tubular bodyportion includes a second shaft disposed radially inward of the annularknife. Desirably, the first shaft of the anvil member is attachable tothe second shaft of the tubular body portion. Accordingly, the methodmay further include the step of attaching the first shaft of the anvilassembly to the second shaft of the tubular body portion prior to thestep of approximating the anvil assembly to the tubular body portion.

The support structure may include an aperture formed therein.Accordingly, the method may further include the step of inserting one ofthe first shaft of the anvil assembly and the second shaft of thetubular body portion into the aperture of the support structure prior tothe step of attaching the first shaft of the anvil assembly to thesecond shaft of the tubular body portion.

The tubular body portion may carry a plurality of surgical staples. Thesurgical staples may be disposed radially outward of the annular knife.Accordingly, in use, firing the surgical anastomosis device includesdeploying the plurality of staples so that the staples penetrate a firstinterstitial section, the support structure and then a secondinterstitial section.

The support structure may include a body and a first and a secondmembrane extending radially outward from the body. Each of the first andsecond membranes of the support structure may be made from a polymericfilm, such as, for example, polyethylene.

In use, expanding the at least one layer of expandable material mayinclude deploying the first and second membranes from a rolled-upcondition to an expanded condition. In the expanded condition, the firstmembrane may extend in a substantially distal direction from the bodyportion of the support structure and the second membrane may extend in asubstantially proximal direction from the body portion of the supportstructure.

The method may further include the step of pulling on at least onerip-cord to expand the first and second membranes.

Each membrane of the support structure may include a first inner layerand a second outer layer. Accordingly, expanding the at least one layermay include expanding the second outer layer at a greater rate than thefirst inner layer. The second outer layer of each membrane of thesupport structure may swell at a rate greater than the first innerlayer.

The second outer layers of the first and second membranes may be madefrom a hydrogel. The first inner layer of each of the first and secondmembranes of the support structure may be constructed from asubstantially non-absorbable material. The first inner layer of each ofthe first and second membranes may be fabricated from a bio-absorbablemesh fabric. The body may be perforated or porous.

The at least one layer of expandable material may expand upon fluidabsorption.

The body may be fabricated from at least one of a polyglactic material,a glycolide homopolymer, and a synthetic absorbable lactomer 9-1material. The body may be a mesh or other fabric.

The body may include a wound treatment material. The wound treatmentmaterial is desirably at least one of an adhesive, a sealant, ahemostat, and a medicament.

The body may be compressible so that the outer terminal edge of the bodyextends beyond the outer radial surface of the anvil and tubular bodyportion. Accordingly, the body may be fabricated from foam. The body hasa first thickness greater than one quarter of a diameter of the body.

The support structure has an unhydrated condition wherein the body has afirst diameter and a first thickness, and a hydrated condition whereinthe body has a second diameter greater than the first diameter and asecond thickness greater than the first thickness. The body desirablyexpands from the first diameter and the first thickness to a seconddiameter and a second thickness upon application of a fluid thereto.

The body may be constructed from a first part of a two-part woundtreatment material, and the fluid applied thereto is a second part ofthe two-part wound treatment material.

According to yet another aspect of the present disclosure, a method ofperforming a surgical anastomosis procedure is provided. The methodincludes the steps of providing an anastomosis apparatus having an anvilassembly movably mounted with respect to a tubular body portion;providing a support structure including a body having an outer terminaledge, and an aperture therethrough, the body being compressible;disposing an anvil assembly into a first intestinal section; disposing adistal end portion of the surgical stapling apparatus in a secondintestinal section; positioning the support structure on a shaft of theanvil assembly; approximating the anvil assembly and the tubular bodyportion to capture the body of the support structure between the firstintestinal section and the second intestinal section and to compress thebody portion therebetween so that the body extends radially beyond theanvil member and the tubular body portion to seal the perimeter of theanastomosis site; and firing the anastomosis apparatus to join the firstintestinal section, support structure, and second intestinal section.

The support structure may have an unhydrated condition wherein the bodyhas a first diameter and a first thickness, and a hydrated conditionwherein the body has a second diameter greater than the first diameterand a second thickness greater than the first thickness. The supportstructure may be pre-mounted onto the shaft of the anvil assembly priorto positioning of the anvil assembly in the first intestinal section.Accordingly, prior to approximating the anvil assembly and the tubularbody portion, the method further includes the step of hydrating thesupport structure to expand the body from the first diameter and thefirst thickness to a second diameter and a second thickness.

The body may be constructed from a first part of a two-part woundtreatment material, and the fluid applied thereto is a second part ofthe two-part wound treatment material.

BRIEF DESCRIPTION OF DRAWINGS

The accompanying drawings, which are incorporated in and constitute apart of this specification, illustrate embodiments of the disclosureand, together with a general description of the disclosure given aboveand the detailed description of the embodiments given below, serve toexplain the principles of the disclosure, wherein:

FIG. 1 is a perspective view of an exemplary annular surgical staplingdevice;

FIG. 2 is a perspective view of a support structure in accordance withan embodiment of the present disclosure, shown in an undeployedcondition;

FIG. 3 is a cross-sectional view of the support structure of FIG. 2, astaken through 3-3 of FIG. 2;

FIG. 4 is a perspective view of the support structure of FIGS. 2 and 3,shown in a deployed condition;

FIG. 5 is a cross-sectional view of the support structure of FIG. 4,shown in the deployed condition;

FIG. 6 is a perspective view of the intestinal area of a patient,illustrating a method of positioning the support structure of FIGS. 2-5on the anvil rod of the annular stapling device of FIG. 1;

FIG. 7 is a schematic perspective view of the intestinal area of FIG. 6,illustrating the anvil rod mounted to the annular stapling device andhaving the support structure of FIGS. 2-5 disposed therebetween;

FIG. 8 is a longitudinal cross-sectional view illustrating the anvil rodmounted to the annular stapling device within a surgical site and thesupport structure of FIGS. 2-5, in an undeployed condition, disposedbetween the apposed surfaces of the tissue;

FIG. 9 is a longitudinal cross-sectional view illustrating the anvil rodmounted to the annular stapling device within a surgical site and thesupport structure of FIGS. 2-5, in a deployed condition, disposedbetween the apposed surfaces of the tissue;

FIG. 10 is a perspective view of an support structure according to analternate embodiment of the present disclosure;

FIG. 11 is a cross-sectional view of the support structure of FIG. 10,as taken through 11-11 of FIG. 10;

FIG. 12 is an enlarged view of the indicated area of detail of FIG. 11;

FIG. 13 is a longitudinal cross-sectional view illustrating the anvilrod mounted to the annular stapling device within a surgical site andthe support structure of FIGS. 10-12, in an undeployed condition,disposed between the apposed surfaces of the tissue;

FIG. 14 is a longitudinal cross-sectional view illustrating the anvilrod mounted to the annular stapling device within a surgical site andthe support structure of FIGS. 10-12, in a deployed condition, disposedbetween the apposed surfaces of the tissue;

FIG. 15 is a perspective view of a support structure according to yetanother alternate embodiment of the present disclosure;

FIG. 16 is a schematic perspective view of an anvil assembly of theannular stapling device of FIG. 1 including yet another supportstructure operatively associated therewith and in an unexpandedcondition;

FIG. 17 is a schematic side elevational view of the anvil assembly ofFIG. 16 illustrating the support structure in an expanded condition;

FIG. 18 is a perspective view of a support structure in accordance withanother embodiment of the present disclosure, for use with the annularsurgical stapling device of FIG. 1;

FIG. 19 is a cross-sectional view of the support structure of FIG. 18,as taken through 19-19 of FIG. 18;

FIG. 20 is a longitudinal cross-sectional view of the intestinal area ofthe patient following placement of the support structure of FIGS. 18 and19 and firing of the surgical stapling apparatus;

FIG. 21 is an enlarged cross-sectional view, of the indicated area ofdetail of FIG. 20;

FIG. 22 is an enlarged cross-sectional view, of the indicated area ofdetail of FIG. 20, illustrating the annular support structure in a firstcondition;

FIG. 23 is an enlarged cross-sectional view, of the indicated area ofdetail of FIG. 20, illustrating the annular support structure in asecond condition;

FIG. 24 is a perspective view of a support structure according to analternate embodiment of the present disclosure;

FIG. 25 is a transverse cross-sectional view of the support structure ofFIG. 24, as taken through 25-25 of FIG. 10;

FIG. 26 is a perspective view of the intestinal area of the patient,illustrating the positioning of the support structure of FIGS. 24 and 25between the anvil assembly and the tubular body portion;

FIG. 27 is a longitudinal cross-sectional view of the intestinal area ofthe patient illustrating the intestinal sections approximated toward oneanother to contact the support structure of FIGS. 24 and 25;

FIG. 28 is a longitudinal cross-sectional view of the intestinal area ofthe patient illustrating the intestinal sections approximated toward oneanother to compress the support structure of FIGS. 24 and 25 between theintestinal sections;

FIG. 29 is a side elevational view of an anvil assembly including thesupport structure of FIGS. 24 and 25, in an unexpanded condition,operatively secured to the stem thereof; and

FIG. 30 is a side elevational view of an anvil assembly including thesupport structure of FIGS. 24 and 25, in an expanded condition,operatively secured to the stem thereof

DETAILED DESCRIPTION OF EMBODIMENTS

Embodiments of the presently disclosed annular adhesive structures willnow be described in detail with reference to the drawing figures whereinlike reference numerals identify similar or identical elements. As usedherein and as is traditional, the term “distal” refers to that portionwhich is furthest from the user while the term “proximal” refers to thatportion which is closest to the user.

Referring initially to FIG. 1, an annular surgical stapling device, foruse with the annular adhesive structures disclosed herein, is generallydesignated as 10. Surgical stapling device 10 includes a handle assembly12 having at least one pivotable actuating handle member 14, and anadvancing member 16. Extending from handle member 12, there is provideda tubular body portion 20 which may be constructed so as to have acurved shape along its length. Body portion 20 terminates in a staplecartridge assembly 22 which includes a pair of annular arrays of staplereceiving slots 36 having a staple (not shown) disposed in each one ofstaple receiving slots 36. Positioned distally of staple cartridgeassembly 22 there is provided an anvil assembly 30 including an anvilmember 26 and a shaft 28 operatively associated therewith for removablyconnecting anvil assembly 30 to a distal end portion or connectionmember 40 of stapling device 10.

Staple cartridge assembly 22 may be fixedly connected to the distal endof tubular body portion 20 or may be configured to concentrically fitwithin the distal end of tubular body portion 20. Typically, staplecartridge assembly 22 includes a staple pusher (not shown) including aproximal portion having a generally frusto-conical shape and a distalportion defining two concentric rings of peripherally spaced fingers(not shown), each one of which is received within a respective staplereceiving slot 36.

Typically, a knife (not shown), substantially in the form of an open cupwith the rim thereof defining a knife edge, is disposed within staplecartridge assembly 22 and mounted to a distal surface of a staple pusher(not shown). The knife edge is disposed radially inward of the pair ofannular arrays of staples. Accordingly, in use, as the staple pusher isadvanced, the knife is also advanced axially outward.

Reference may be made to U.S. Pat. No. 5,915,616 to Viola et al., theentire content of which is incorporated herein by reference, for adetailed discussion of annular stapling device 10.

Turning now to FIGS. 2-9, an annular adhesive or support structure, inaccordance with an embodiment of the present disclosure, is generallydesignated as 100. Structure 100 includes a washer-like or disk-likebody 102 including a substantially centrally located aperture 104 formedtherethrough. Structure 100 is defined by an outer terminal edge 106, aninner terminal edge 108 defining the size of aperture 104, an uppersurface 110, and a bottom surface 112.

In one embodiment, structure 100 is sized such that when structure 100is operatively associated with stapling device 10, as will be describedin greater detail below, outer terminal edge 106 extends radially beyondstaple retaining pockets 36 of staple cartridge assembly 22.Additionally, aperture 104 of structure 100 is sized to at least receiveshaft 28 of anvil assembly 30 therethrough. In another embodiment, thedistance between outer terminal edge 106 and inner terminal edge 108 issubstantially equal to a width of a tissue contact surface 24 (seeFIG. 1) of staple cartridge assembly 22.

It is contemplated that body 102 of structure 100 may be fabricated fromor include a surgical grade, biocompatible, non-absorbable (i.e.,permanent) mesh or material desirably impregnated with an adhesive,sealant and/or other medicament. For example, body 102 may be fabricatedfrom “TEFLON”, which is a registered trademark owned by DuPont deNemours & Co. It is further contemplated that body 102 may be fabricatedfrom a biocompatible polymeric foam, felt, polytetrafluoroethylene(PTFE), gelatin, fabric or the like, or any other biocompatiblematerial.

Non-absorbable materials used for body 102 include, and are not limitedto, those that are fabricated from such polymers as polyethylene,polypropylene, nylon, polyethylene terephthalate,polytetrafluoroethylene, polyvinylidene fluoride, and the like. Furthernon-absorbable materials include and are not limited to stainless steel,titanium and the like.

In one embodiment, body 102 of structure 100 may be fabricated from abio-absorbable material which is desirably impregnated with an adhesive,sealant, and/or other medicament (i.e., wound treatment material).Accordingly, in use, the sealant component of structure 100 functions toretard any bleeding which may occur from the tissue, the adhesivecomponent of structure 100 functions to secure the approximated tissuetogether, and the bio-absorbability of structure 100 allows for the atleast a portion of structure 100 to be absorbed into the body after apredetermined amount of time. For example, structure 100 may remain inplace in the body for approximately 2-3 weeks in order for theanastomosis to sufficiently heal prior to structure 100 being absorbedinto the body.

Bio-absorbable materials used for body 102 of structure 100 include, andare not limited to, those fabricated from homopolymers, copolymers orblends obtained from one or more monomers selected from the groupconsisting of glycolide, glycolic acid, lactide, lactic acid,p-dioxanone, α-caprolactone, dioxanone, polyalkylene oxides, andtrimethylene carbonate. Other bio-absorbable materials include and arenot limited to, for example, Polyglycolic Acid (PGA) and Polylactic Acid(PLA). In one embodiment, body 102 may be fabricated from bio-absorbablefelt, PTFE, gelatin or any other bio-absorbable materials. Illustrativeexamples of bioabsorbable materials include DEXON™ mesh, absorbablefelts, such as POLYSORB™, and foams, such as polyurethane.

It is envisioned that body 102 of structure 100 may be impregnated witha wound treatment material “W” which is a pre-cured adhesive or sealant.The pre-cured sealant or adhesive will react with the moisture and/orheat of the body tissue to thereby activate the sealing and/or adhesiveproperties of the sealant or adhesive. It is envisioned that thepre-cured sealant or adhesive may be a hydro-gel or the like.

It is contemplated that the wound treatment material “W” is any materialfor joining, healing, sealing or otherwise treating tissue. In apreferred embodiment, the wound treatment material is a bio-compatiblesealant, including, and not limited, to sealants which cure upon tissuecontact, sealants which cure upon exposure to ultraviolet (UV) light,sealants which are multiple-part systems, including two-part systemswhich are kept isolated from one another and are combined, or anycombinations thereof. Any known suitable adhesive may be used. In oneembodiment, it is contemplated that such sealants and/or adhesives arecurable. For example, sealants may have a cure time of from about 10 to15 seconds may be used. In preferred embodiments, the sealant and/oradhesive is a bioabsorbable and/or bio-resorbable material. In anotherembodiment, it is contemplated that a sealant and/or adhesive having acure time of about 30 seconds may be used. It is further envisioned thatwound treatment material “W” may be a pre-cured adhesive or sealant.

In certain preferred embodiments, the wound treatment material comprisesa sealant. Such a sealant is desirably a PEG-based material. Examples ofclasses of materials useful as the sealant and/or adhesive includeacrylate or methacrylate functional hydrogels in the presence of abiocompatible photoinitiator, alkyl-cyanoacrylates, isocyanatefunctional macromers with or without amine functional macromers,succinimidyl ester functional macromers with amine or sulfhydrylfunctional macromers, epoxy functional macromers with amine functionalmacromers, mixtures of proteins or polypeptides in the presence ofaldehyde crosslinkers, Genipin, or water-soluble carbodiimides, anionicpolysaccharides in the presence of polyvalent cations, etc.

Some specific materials which may be utilized include isocyanateterminated hydrophilic urethane prepolymers derived from organicpolyisocyanates and oxyethylene-based diols or polyols, including thosedisclosed in U.S. Pat. Nos. 6,702,731 and 6,296,607 and U.S. PublishedPatent Application No. 2004/0068078; alpha-cyanoacrylate based adhesivesincluding those disclosed in U.S. Pat. No. 6,565,840; alkyl ester basedcyanoacrylate adhesives including those disclosed in U.S. Pat. No.6,620,846; adhesives based on biocompatible cross-linked polymers formedfrom water soluble precursors having electrophilic and nucleophilicgroups capable of reacting and cross-linking in situ, including thosedisclosed in U.S. Pat. No. 6,566,406; two part adhesive systemsincluding those based upon polyalkylene oxide backbones substituted withone or more isocyanate groups in combination with bioabsorbable diaminecompounds, or polyalkylene oxide backbones substituted with one or moreamine groups in combination with bioabsorbable diisoycanate compounds asdisclosed in U.S. Published Patent Application No. 2003/0032734, thecontents of which are incorporated by reference herein; and isocyanateterminated hydrophilic urethane prepolymers derived from aromaticdiisocyanates and polyols as disclosed in U.S. Published PatentApplication No. 2004/0115229, the contents of which are incorporated byreference herein.

It is envisioned and within the scope of the present disclosure thatwound treatment material “W” may include one or a combination ofadhesives, hemostats, sealants, or any other tissue or wound-treatingmaterial. Surgical biocompatible wound treatment materials “W”, whichmay be used in accordance with the present disclosure, include adhesiveswhose function is to attach or hold organs, tissues or structures,sealants to prevent fluid leakage, and hemostats to halt or preventbleeding. Examples of adhesives which can be employed include proteinderived, aldehyde-based adhesive materials, for example, thecommercially available albumin/glutaraldehyde materials sold under thetrade designation BioGlue™ by Cryolife, Inc., and cyanoacrylate-basedmaterials sold under the trade designations Indermil™ and Derma Bond™ byTyco Healthcare Group, LP and Ethicon Endosurgery, Inc., respectively.Examples of sealants, which can be employed, include fibrin sealants andcollagen-based and synthetic polymer-based tissue sealants. Examples ofcommercially available sealants are synthetic polyethylene glycol-based,hydrogel materials sold under the trade designation CoSeal™ by CohesionTechnologies and Baxter International, Inc. Examples of hemostatmaterials, which can be employed, include fibrin-based, collagen-based,oxidized regenerated cellulose-based and gelatin-based topicalhemostats. Examples of commercially available hemostat materials arefibrinogen-thrombin combination materials sold under the tradedesignations CoStasis™ by Tyco Healthcare Group, LP, and Tisseel™ soldby Baxter International, Inc. Hemostats herein include astringents,e.g., aluminum sulfate, and coagulants.

The medicament may include one or more medically and/or surgicallyuseful substances such as drugs, enzymes, growth factors, peptides,proteins, pigments, dyes, diagnostic agents or hemostasis agents,monoclonal antibodies, or any other pharmaceutical used in theprevention of stenosis. The medicament may be disposed on structure 100or impregnated into structure 100. The medicament may include one ormore medically and/or surgically useful substances such as drugs,enzymes, growth factors, peptides, proteins, dyes, diagnostic agents orhemostasis agents, monoclonal antibodies, or any other pharmaceuticalused in the prevention of stenosis.

Wound treatment material “W” may include visco-elastic film formingmaterials, cross-linking reactive agents, and energy curable adhesives.It is envisioned that wound treatment material “W”, and in particular,adhesive may be cured with the application of water and/or glycerinthereto. In this manner, the water and/or glycerin cure the adhesive andhydrate the wound.

It is further contemplated that wound treatment material “W” mayinclude, for example, compositions and/or compounds which accelerate orbeneficially modify the healing process when particles of thecomposition and/or compound are applied to or exposed to a surgicalrepair site. For example, the wound treatment material “W” may be atherapeutic agent which will be deposited at the repair site. Thetherapeutic agent can be chosen for its antimicrobial properties,capability for promoting repair or reconstruction and/or new tissuegrowth. Antimicrobial agents such as broad spectrum antibiotic(gentamycin sulfate, erythromycin or derivatized glycopeptides) whichare slowly released into the tissue can be applied in this manner to aidin combating clinical and sub-clinical infections in a tissue repairsite. To promote repair and/or tissue growth, wound treatment material“W” may include one or several growth promoting factors, e.g.,fibroblast growth factor, bone growth factor, epidermal growth factor,platelet derived growth factor, macrophage derived growth factor,alveolar derived growth factor, monocyte derived growth factor,magainin, and so forth. Some therapeutic indications are: glycerol withtissue or kidney plasminogen activator to cause thrombosis, superoxidedimutase to scavenge tissue damaging free radicals, tumor necrosisfactor for cancer therapy or colony stimulating factor and interferon,interleukin-2 or other lymphokine to enhance the immune system.

In one embodiment, it is contemplated that body 102 of structure 100 maybe impregnated with a first component of a multiple-part adhesive andthat the staples, retained in staple receiving slots 36 of staplecartridge assembly 22, may be coated with a second component (e.g., areactant) of the multiple-part adhesive. In this manner, the firstcomponent of the adhesive is activated when the staples penetrate andcapture body 102 of structure 100 during the firing sequence of surgicalstapling device 10, and the two components of the adhesive contact oneanother.

As seen in FIGS. 2-9, in an embodiment annular support structure 100includes at least one, preferably a pair of drapes, skirts or membranes140, 142 (e.g., a first membrane 140 and a second membrane 142)extending from outer terminal edge 106 of body 102. Desirably, membranes140, 142 are fabricated from a polymeric or plastic film including andnot limited to polyethylene and the like. Each membrane 140, 142includes a first or outer surface 140 a, 142 a, respectively, and asecond or inner surface 140 b, 142 b, respectively.

As seen in FIGS. 2 and 3, membranes 140, 142 have a first, undeployedcondition wherein membranes 140, 142 are rolled-up towards body 102.Desirably, membranes 140, 142 are rolled under in a direction toward thefirst or outer surfaces 140 a, 142 a thereof, as indicated by arrows “A”of FIG. 3. As seen in FIGS. 4 and 5, membranes 140, 142 have a second,deployed condition wherein membranes 140, 142 are unrolled or unfurledto extend in a substantially parallel orientation with respect to thecentral “X” axis. As will be described in greater detail below, firstmembrane 140 is unrolled in a first direction, preferably in a distaldirection (e.g., in a direction substantially orthogonal to uppersurface 110 of body 102), and second membrane 142 is unrolled in asecond direction, preferably in a proximal direction (e.g., in adirection substantially orthogonal to lower surface 112 of body 102).

As seen in FIGS. 2 and 3, support structure 100 desirably includes arip-cord or tether 144, 146 rolled-up into membranes 140, 142. Rip-cords144, 146 include free ends 144 a, 146 a which extend from membranes 140,142 when membranes 140, 142 are in the rolled-up condition. In thismanner, as will be described in greater detail below, as rip-cords 144,146 are pulled, desirably in a distal direction (e.g., orthogonal toupper surface 110 of body 102) and a proximal direction (e.g.,orthogonal to lower surface 112 of body 102), membranes 140, 142 areun-rolled or un-furled accordingly.

In one embodiment, it is envisioned that body 102 of support structure100 is formed of a foam material overmolded onto a relatively thinflexible material or film making up membranes or sleeves 140, 142.Desirably, when un-rolled or un-furled, each membrane 140, 142 extendsapproximately 2.0 cm from body 102. In other words, when un-rolled orun-furled, first membrane 140 extends from body 102 by approximately 2.0cm from upper surface 110 of body 102, and second membrane 142 extendsfrom body 102 approximately 2.0 cm from lower surface 112 of body 102.

Turning now to FIGS. 6-9, there is illustrated the use of surgicalstapling device 10 and support structure 100 in an anastomosis procedureto effect joining of intestinal sections 66 and 68. The anastomosisprocedure is typically performed using minimally invasive surgicaltechniques including laparoscopic means and instrumentation. At thepoint in the procedure shown in FIG. 6, a diseased intestinal sectionhas been previously removed, anvil assembly 30 has been introduced tothe operative site either through a surgical incision or trans-anallyand positioned within intestinal section 68, and tubular body portion 20of surgical stapling device 10 has been inserted trans-anally intointestinal section 66. Intestinal sections 66 and 68 are also showntemporarily secured about their respective components (e.g., shaft 28 ofanvil assembly 30, and the distal end of tubular body portion 20) byconventional means such as a purse string suture “P”.

Annular support structure 100 is then placed onto shaft 28 of anvilassembly 30 prior to the coupling of anvil assembly 30 to the distal endof tubular body portion 20. In particular, shaft 28 of anvil assembly 30is inserted into aperture 104 of body portion 102. Following positioningof structure 100 onto shaft 28 of anvil assembly 30, the surgeonmaneuvers anvil assembly 30 until the proximal end of shaft 28 isinserted into the distal end of tubular body portion 20 of surgicalstapling device 10, wherein the mounting structure (not shown) withinthe distal end of tubular body portion 20 engages shaft 28 to effect themounting.

Thereafter, as seen in FIG. 8, anvil assembly 30 and tubular bodyportion 20 are approximated to approximate intestinal sections 66, 68and capture body 102 of annular support structure 100 therebetween. Withbody 102 captured between intestinal sections 66, 68, as seen in FIG. 9,membranes 140, 142 are deployed (i.e., un-rolled or un-furled) asdescribed above. In particular, first membrane 140 is un-rolled orun-furled in a distal direction, as indicated by arrow “B”, so as toover-lie intestinal section 68, and second membrane 142 is un-rolled orun-furled in a proximal direction, as indicated by arrow “C”, so as toover-lie intestinal section 66. Desirably, first and second membranes140, 142 are un-rolled or un-furled by pulling on rip-cords 144, 146 ina distal or proximal direction, as necessary.

Membranes 140, 142 extend a predetermined distance over intestinalsections 66 and 68 (e.g., approximately 2 cm). When un-rolled orun-furled, membranes 140, 142 will adhere to the surface of intestinalsections 66, 68. Membranes 140 and 142 function to inhibit leakage fromthe anastomosis site and/or function to strengthen or reinforceintestinal sections 66, 68. With membranes 140, 142 deployed, as seen inFIG. 15, surgical stapling device 10 may be fired thereby staplingintestinal sections 66, 68 to one another and cutting the portion oftissue and structure 100 disposed radially inward of the knife, tocomplete the anastomosis.

Turning now to FIGS. 10-14, annular support structure 100 includes atleast one, preferably a pair of membranes 150, 152 (e.g., a firstmembrane 150 and a second membrane 152) extending from outer edge 106 ofbody 102. Each membrane 150 and 152 includes two layers, an inner layer150 a, 152 a, respectively, and an outer layer 150 b, 152 b,respectively. Desirably, the materials selected for the construction ofmembranes 150, 152 swell at different rates when in the presence ofmoisture or fluid. In this manner, membranes 150, 152 will tend to bendor curl about the layer having the relatively slower rate of fluidswelling or fluid absorption. In this manner, support structure 100 hasa first undeployed condition in which membranes 150, 152 extendsubstantially radially outward from body 102, and a second deployedcondition in which membranes 150, 152 are substantially aligned with thecentral “X” axis of body 102.

In accordance with one embodiment, it is envisioned that inner layer 150a, 152 a of membranes 150, 152 are constructed from a substantiallynon-absorbable (i.e., does not absorb moisture therein) or non-expanding(i.e., static) material, such as, for example, a bio-absorbable orresorbable mesh fabricated from polyglycolic acid, sold under thetradename DEXON™, available from Tyco Healthcare Group LP, Norwalk,Conn. Other mesh, knit, woven and non-woven materials may be used. It isalso envisioned that outer layer 150 b, 152 b of membranes 150, 152 areconstructed from an absorbable, resorbable or expanding (i.e., dynamic)material, such as, for example, hydrogel and the like.

Desirably, each membrane 150 and 152 includes a hydrogel outer layer 150b, 152 b laminated to a bio-absorbable mesh inner layer 150 a, 152 a.Furthermore, support structure 100 includes a foam body 102 laminatedover a pair of dual layered membranes 150, 152. While each membrane 150,152 desirably includes a pair of layers, it is envisioned and within thescope of the present disclosure for membranes 150, 152 to include anynumber of layers.

Accordingly, with reference to FIG. 12, the difference in materialproperties between inner layers 150 a, 152 a and outer layers 150 b, 152b of membranes 150, 152 cause membranes 150, 152 to curl or bend fromthe undeployed condition, wherein membranes 150, 152 extend in asubstantially radial direction, to a deployed condition, whereinmembranes 150, 152 extend in a direction substantially parallel to thecentral “X” axis (as shown in phantom in FIG. 12).

Turning now to FIGS. 13 and 14, there is illustrated the use of surgicalstapling device 10 and support structure 100 including membranes 150,152 in an anastomosis procedure to effect joining of intestinal sections66 and 68. At the point in the procedure shown in FIG. 13, anvilassembly 30 and tubular body portion 20 are shown approximated to oneanother to capture body 102 of annular support structure 100 betweenintestinal sections 66 and 68, wherein intestinal section 66 and 68 werepreviously secured about their respective components (e.g., shaft 28 ofanvil assembly 30, and the distal end of tubular body portion 20) byconventional means such as a purse string suture “P”, annular supportstructure 100 was positioned between intestinal sections 66 and 68, andanvil assembly 30 was coupled to the distal end of tubular body portion20.

With body portion 102 of support structure 100 captured betweenintestinal sections 66, 68, as seen in FIGS. 13 and 14, membranes 150,152 begin to deploy (i.e., curl or bend from the substantially radiallyextended orientation to the orientation substantially parallel with thecentral “X” axis) as described above. In particular, as outer layers 150b, 152 b of first and second membranes 150, 152 absorb fluid and swell(i.e., expand), first and second membranes 150, 152 curl or bend to theside of membrane 150, 152 which swells or expands at a rate slower,i.e., toward inner layers 150 a, 152 a. As membranes 150, 152 aredeployed, as indicated by arrow “B”, first membrane 150 over-liesintestinal section 68, and second membrane 152 over-lies intestinalsection 66, as indicated by arrow “C”.

Desirably, membranes 150, 152 extend a predetermined distance overintestinal sections 66 and 68 (e.g., approximately 2 cm). Accordingly,when deployed, membranes 150, 152 will adhere to the surface ofintestinal sections 66, 68. Membranes 150, 152 function to inhibitleakage from the anastomosis site and/or function to strengthen orreinforce intestinal sections 66, 68. With membranes 150, 152 deployed,as seen in FIG. 14, surgical stapling device 10 may be fired therebystapling intestinal sections 66, 68 to one another and cutting theportion of tissue and structure 100 disposed radially inward of theknife, to complete the anastomosis.

As seen in FIG. 15, annular support structure 100 includes a series ofribs 156, 158 provided on and/or in each membrane 150, 152,respectively. Desirably, ribs 156, 158 extend radially around theperimeter or circumference of membranes 150, 152. Ribs 156, 158 aresubstantially radially oriented.

Ribs 156, 158 are fabricated from a shape memory material, alloy or thelike, preferably, NITINOL™ and the like. It is further envisioned thatribs 156, 158 may be fabricated from a bio-absorbable material.

Ribs 156, 158 have a memorized shape which is oriented substantiallyparallel to the central “X” axis of support structure 100. In thismanner, support structure 100 has a first or un-deployed condition inwhich ribs 156, 158 are in a biased rolled-up condition and membranes150, 152 are also rolled-up, and a second or deployed condition in whichribs 156, 158 are in their memorized shape or condition and membranes150, 152 are extended.

In use, with support structure in an un-deployed condition, supportstructure 100 is positioned in shaft 28 of anvil assembly 30. Withsupport structure 100 so positioned, support structure 100 is deployedwhen ribs 156, 158 return to their memorized conditions. In particular,the return of ribs 156, 158 to their memorized conditions extendsmembranes 150, 152 over intestinal sections 66 and 68 and/or in adirection substantially parallel to the central “X” axis.

Turning now to FIGS. 18-28, a support structure in accordance with analternate embodiment is generally designated as 200. Support structure200 is substantially similar to support structure 100 and will only bedescribed in detail to the extent necessary to identify differences inconstruction and operation.

As seen in FIGS. 18 and 19, body 202 of support structure 200 includes aplurality of pores 214 extending therethrough. Desirably, pores 214 aresubstantially parallel with the longitudinal “X” axis of body 202. Pores214 allow for healing to take place between a pair of apposed tissuesurfaces. Additionally, since pores 214 are substantially parallel tothe longitudinal “X” axis, leakage of fluid from the anastomotic site isreduced. While body 202 has been shown and described as including pores214, it is envisioned and within the scope of the present disclosurethat body 202 may be perforated or may be constructed from a porousmaterial.

With continued reference to FIGS. 18 and 19, support structure 200includes a rim or layer 220 of fluid expanding or water-swellablematerial, e.g., a hydrogel, disposed around outer terminal edge 206 ofbody 202. Hydrogels contemplated for support structure 200 areidentified in U.S. Pat. No. 5,505,952 to Jiang et al., the entirecontent of which is incorporated herein by reference.

Turning now to FIGS. 20-23, there is illustrated the use of supportstructure 200 in an anastomosis procedure to effect joining ofintestinal sections 66 and 68. The anastomosis procedure is typicallyperformed using minimally invasive surgical techniques includinglaparoscopic means and instrumentation. At the point in the procedureshown in FIG. 20, support structure 200 has been placed onto shaft 28 ofanvil assembly 30, the anvil assembly 30 has been coupled to the distalend of tubular body portion 20 of surgical stapling device 10, andsurgical stapling device 10 has been fired thereby stapling intestinalsections 66, 68 to one another and cutting the portion of tissue andsupport structure 200 disposed radially inward of the knife, to completethe anastomosis.

As seen in FIG. 21, pores 214 of body 202 allow for in-growth ofintestinal sections 66, 68 therein thereby improving the healingprocess. In particular, pores 214 of body 202 reduce the time requiredfor intestinal sections 66, 68 to contact one another during the healingprocess. For example, depending on the size of pores 214 of body 202,intestinal sections 66, 68 may contact one another immediately followingthe firing of surgical stapling device 10, or pores 214 of body 202define channels into which intestinal sections 66, 68 may grow and comeinto contact with one another over time.

As seen in FIG. 22, initially, following placement of support structure200 into position between intestinal sections 66, 68 and firing ofsurgical stapling device 10, rim 220 of support structure 200 is in afirst or unexpanded (i.e., un-swelled) condition. Subsequently, as seenin FIG. 23, with support structure 200 in position between intestinalsections 66, 68, rim 220 thereof begins to absorb moisture from thesurrounding environment (e.g., water, saline, blood, etc.) and expand toa second or swelled condition. In one method, it is envisioned thatfluid may be dispensed onto the anastomosis site, especially onto rim220 of support structure 200 in order to cause expanding and/or swellingof rim 220.

As seen in FIG. 23, as rim 220 of support structure 200 swells orexpands, the radial gap “G” between intestinal sections 66, 68 fills.Accordingly, rim 220, when in the swelled or expanded condition acts asa seal, darn, stopper, barrier or the like to inhibit and/or prevent theleakage of the contents of the bowel into the abdominal region of thepatient. In other words, the swelling of rim 220 results in theformation of a gasket-like seal around the outside of the anastomosis.

Turning now to FIGS. 24-28, a support structure, in accordance with analternate embodiment of the present disclosure, is generally designatedas 300. As seen in FIGS. 24 and 25, body 302 of support structure 300may be formed entirely of resilient compressible foam or sponge-likematerial fabricated from a bio-absorbable material or any otherbio-compatible material disclosed above with regard to support structure100. Desirably, as seen in FIG. 25, body 302 of support structure 300has an initial height or thickness “T1” (e.g., the height or thicknesswhen body 302 is fully expanded). Desirably, body 302 has a diameter “D”which is at least equal to a diameter of tubular body portion 20 and/oranvil member 26. Most desirably, the diameter “D” of body portion ofsupport structure 300 is greater than the diameters of tubular body 20and/or anvil member 26. Desirably, thickness “T1” is greater than aquarter of the diameter “D”, when in the initial uncompressed condition.

Turning now to FIGS. 26-28, there is illustrated the use of surgicalstapling device 10 and support structure 300 in an anastomosis procedureto effect joining of intestinal sections 66 and 68. As seen in FIGS. 27and 28, with a support structure 300 positioned on shaft 28 of anvilassembly 30 and disposed between intestinal sections 66, 68, as anvilassembly 30 and tubular body portion 20 are approximated, body 302 ofsupport structure 300 is compressed therebetween. In particular, as seenin FIG. 27, prior to complete approximation, body 302 of supportstructure 300 is uncompressed and desirably extends radially beyond theouter terminal edges of tubular body portion 20 and/or anvil member 26.In particular, body 302 of support structure 300 has a thicknesssubstantially equal to “T1”. Thereafter, upon complete approximation,body 302 of support structure 300, in the region disposed betweentubular body portion 20 and anvil member 26, is compressed therebetweento a thickness “T2”. Accordingly, the portion of support structure 300disposed radially outward of tubular body portion 20 and anvil member 26remains substantially uncompressed (e.g., having a thicknessapproximately equal to “T1”) thereby filling and/or sealing the radialgap “G” between intestinal sections 66, 68.

In addition to reducing leakage from the anastomosis site, due to thecompressible nature of body 302 of support 300, the body 302 is capableof filling any voids or recesses which may exist in the surface ofintestinal sections 66, 68.

Following the approximation of anvil assembly 30 and tubular bodyportion 20, to approximate intestinal sections 66, 68 and capture body302 of support structure 300 therebetween, surgical stapling device 10is fired thereby stapling intestinal sections 66, 68 to one another andcutting the portion of tissue and support structure 300 disposedradially inward of the knife, to complete the anastomosis.

As seen in FIG. 29, support structure 300 may have an unexpanded (e.g.,collapsed or un-hydrated condition) in which body 302 of supportstructure 300 has a first diameter “D1” and a first thickness “T1”.Additionally, as seen in FIGS. 29 and 30, anvil assembly 30 includes anetwork of channels 28 a formed in shaft 28 which are configured andarranged to dispense fluid onto and/or direct fluid into body 302 ofsupport structure 300. While channels 28 a have been shown anddescribed, any structure for delivering fluid to body 302 of supportstructure 300 is contemplated by the present disclosure.

As seen in FIG. 30, fluid “F” is delivered to body 302 of supportstructure 300 thereby causing body 302 of support structure 300 toexpand radially and longitudinally. In other words, the application offluid “F” to body 302 of support structure 300 causes body 302 ofsupport structure 300 to expand and hydrate. In the expanded condition,body 302 of support structure 300 has a second diameter “D2”, largerthan first diameter “D1”, and a second thickness “T2”, larger than firstthickness “T1”.

In use, with support structure 300 in the un-expanded condition, anvilassembly 30 is introduced into the surgical site as described above.Following connection of anvil assembly 30 to the distal end of tubularbody portion 20, fluid “F” is delivered to body 302 of support structure300, thereby causing support structure 300 to expand. Followingexpansion of support structure 300, the surgical procedure is continuedas described above.

It is envisioned and within the scope of the present disclosure that thefluid “F” may be a cross-linker or other substance which is reactivewith the foam of body 302 of support structure 300 to thereby form orcreate a support structure 300 of wound treatment material (e.g.,adhesive, sealant, hemostat, medicament, etc.). It is contemplated thatbody 302 of support structure 300 may be a foam made from a first partof a multiple-part wound treatment material, and fluid “F” may include asecond part of the multiple-part wound treatment material. In thismanner, the wound treatment material is formed upon interaction of fluid“F” with body 302 of support structure 300.

From the foregoing, it will be appreciated that the support structuresof the present disclosure function to strengthen the anastomosis andreduce the occurrence of bleeding, leaking and stricture. It is also tobe appreciated that the support structures of the present disclosure maybe utilized in a number of other applications and is not limited solelyto bowel or bronchus anastomosis.

While several particular fowls of the support structures have beenillustrated and described, it will also be apparent that variousmodifications can be made without departing from the spirit and scope ofthe present disclosure. For example, it is envisioned and within thescope of the present disclosure for an ultraviolet light activatedadhesive to be used in connection with any of the support structuresdescribed above. In use, either prior to or following firing of surgicalstapling device 10, the support structure is irradiated with UV light tothereby activate the adhesive thereof.

It is further contemplated that each of the support structures describedherein may be used with an annular surgical anastomosing device, notincluding any staples for securing tissue together, which is capable ofapproximating, adhering and cutting tissue.

Thus, it should be understood that various changes in form, detail andapplication of the support structures of the present disclosure may bemade without departing from the spirit and scope of the presentdisclosure.

What is claimed is:
 1. A method of disposing a support structure betweenadjacent intestinal sections, comprising the steps of: providing acircular surgical anastomosis device, the circular surgical anastomosisdevice including: an anvil assembly having an anvil member and a firstshaft; and a tubular body portion having an annular knife operativelydisposed therein and a second shaft disposed radially inward of theannular knife, the first shaft of the anvil assembly being selectivelyattachable to the second shaft of the tubular body; inserting the anvilassembly into a first intestinal section; inserting the tubular bodyportion into a second intestinal section; disposing a support structurebetween the first intestinal section and the second intestinal section,the support structure having a body having an outer terminal edge and atleast one layer of expandable material extending radially outward fromthe outer terminal edge; approximating the anvil assembly and tubularbody portion with one another so that an end portion of the firstintestinal section, the support structure, and an end portion of thesecond intestinal section are disposed between the anvil member and thetubular body portion, the support structure being disposed between thefirst intestinal section and the second intestinal section; firing thesurgical anastomosis device to sever the portions of the first andsecond intestinal sections disposed radially inward of the annularknife, and to touch the portions of the first and second intestinalsections radially outward of the annular knife against the structure;and expanding the at least one layer of expandable material.
 2. Themethod according to claim 1, wherein: the anvil assembly includes afirst shaft and a tubular body portion includes a second shaft disposedradially inward of the annular knife, the first shaft of the anvilmember being attachable to the second shaft of the tubular body portion;and further including the step of attaching the first shaft of the anvilassembly to the second shaft of the tubular body portion prior to thestep of approximating the anvil assembly to the tubular body portion. 3.The method according to claim 2, wherein: the support structure includesan aperture formed therein; and further including the step of insertingone of the first shaft of the anvil assembly and the second shaft of thetubular body portion into the aperture of the support structure prior tothe step of attaching the first shaft of the anvil assembly to thesecond shaft of the tubular body portion.
 4. The method according toclaim 3, wherein the tubular body portion carries a plurality ofsurgical staples, the surgical staples being disposed radially outwardof the annular knife and wherein in firing the surgical anastomosisdevice includes deploying the plurality of staples so that the staplespenetrate first interstitial section, the support structure and then asecond interstitial section.
 5. The method according to claim 1, whereinthe support structure includes: a first and a second membrane extendingradially outward from the body.
 6. The method according to claim 5,wherein each of the first and second membranes of the support structureis made from a polymeric film.
 7. The method according to claim 5,wherein each of the first and second membranes of the support structureis made from polyethylene.
 8. The method according to claim 5, whereineach membrane of the support structure includes a first inner layer anda second outer layer.
 9. A method of performing a surgical anastomosisprocedure, comprising the steps of: providing an anastomosis apparatushaving an anvil assembly movably mounted with respect to a tubular bodyportion; providing a support structure including a body having an outerterminal edge, and an aperture therethrough, the body beingcompressible; disposing an anvil assembly into a first intestinalsection; disposing a distal end portion of the surgical staplingapparatus in a second intestinal section; positioning the supportstructure on a shaft of the anvil assembly; approximating the anvilassembly and the tubular body portion to capture the body of the supportstructure between the first intestinal section and the second intestinalsection and to compress the body portion therebetween so that a portionof the body extends radially beyond the anvil member and the tubularbody portion, at a location between the first and second intestinalsections, and remains substantially uncompressed thereby sealing aradial gap between the first intestinal section and the secondintestinal section of the anastomosis site; and firing the anastomosisapparatus to join the first intestinal section, support structure, andsecond intestinal section.
 10. The method according to claim 9, whereinthe support structure has an unhydrated condition wherein the body has afirst diameter and a first thickness, and a hydrated condition whereinthe body has a second diameter greater than the first diameter and asecond thickness greater than a first thickness.
 11. The methodaccording to claim 10, wherein the support structure is premounted ontothe shaft of the anvil assembly prior to positioning of the anvilassembly in the first intestinal section, wherein prior to approximatingthe anvil assembly and the tubular body portion, the method furtherincludes the step of hydrating the support structure to expand the bodyfrom the first diameter and the first thickness to a second diameter anda second thickness.
 12. The method according to claim 11, wherein thebody is constructed from a first part of a multiple-part wound treatmentmaterial, and the fluid applied thereto is a second part of themultiple-part wound treatment material.